Releases and Updates to IRBMED Website

 

4/30/2012: CHANGES TO THE HSIP FORM: The Human Subject Incentives Program (HSIP) request form now enables users to attach and upload a spreadsheet or PDF with subject details directly into the request. Many of you may currently submit subject details to the HSIP office as an email attachment, which creates electronic records in an additional system. Uploading them directly into the HSIP request form eliminates these additional records and streamlines the HSIP process. HSIP recommends that you begin using the new file attach mechanism in the HSIP system immediately to submit your subject details. The HSIP office will no longer accept e-mail attachments as of Friday, May 11, 2012. The HSIP job aid in MyLINC has been updated with information on how to use the new file attach functionality: https://maislinc.umich.edu/mais/pdf/HSIP_PmtRequest_Create_SS.pdf. Please contact subject-incentives@umich.edu if you have any questions.

4/16/2012: STAFF CHANGES: Judith Birk, former Director of IRB-HSBS, has accepted the position of Director for IRBMED. Carol Hutsko, former JARA for the A2 Board, has accepted the position of SARA for the B1 Board

4/16/ 2012: CONTACT INFORMATION: IRBMED has created a new Contacts page with contact information for IRBMED Co-Chairs, Vice-Chairs, and staff.  There are also links to search by medical specialty or by team.  You can access the new page by selecting About IRB in the left box or by clicking here.

4/11/ 2012: EDUCATION & TRAINING VIDEO UPDATE: We have added a new slide presentation to our Education & Training Videos page. This four-minute presentation explores using eResearch notes as reminders to complete all required sections of your application before submitting it to IRBMED.

4/10/2012: GLOSSARY: IRBMED has compiled a glossary of regulations, terms, and acronyms related to human subjects research. The contents of this glossary have been collected from a variety of authoritative sources.  You can access the glossary by selecting Guidance on the IRBMED Homepage or by clicking here.

4/2/2012: EDUCATION & TRAINING: IRBMED is pleased to announce the initial roll-out of the new Education & Training Program, effective immediately. Over the next several months, we will continue to open new course offerings, so please check back for updates. To view the redesigned education pages and course offerings, please click here.We would like to thank all of the members of the research community who provided direction, guidance, and feedback while we developed this new educational model. We are committed to ensuring that this program is tailored to meet the needs of the research community, and look forward to continued collaboration.

3/20/2012: ADVERSE EVENT DEFINITIONS: Our guidance page now includes a direct link to OHSR’s adverse event terminology. Researchers use these terms to identify events’ severity, expectedness, and relatedness to research.

3/6/2012: MiChart: On February 29, 2012, the MiChart team at MICHR released a newsletter with information regarding the use of MiChart in relation to ongoing and future research projects.  For more information or to access the newsletter, click here: http://www.med.umich.edu/i/michart/ Please direct any questions to:  MiChart-Questions@umich.edu.

2/10/2012: EDUCATION & TRAINING: Our education team is currently collaborating with members of the research community in order to redesign IRBMED’s education program.  The goal is to make sure this new program is tailored to meet the needs of the research community, and we are dedicated to entirely replacing the existing curriculum and offerings.

1/31/2012: CONSULTATIONS: IRBMED offers consults on various human subjects’ research protection topics.  These educational consults are designed for small groups (typically less than 10 people).  For information about what topics are offered or to request a consult, click here.

1/16/2012: MEET THE IRBMED: Thank you to all who attended. We appreciated all of the great questions and hope that the session was beneficial. If you would like to review the presentation, you may access it by clicking here. A list of the Questions and Answers will be available soon. We would also like to especially thank the panelists for sharing their knowledge and expertise and all of the people that worked behind the scenes to make this event a success.

1/4/2012: PRIVACY BOARD: Under Education on the Privacy Board page, discussion points, questions, and PowerPoint slides from October 18th's Research Privacy and HIPAA panel discussion are now available online.

1/3/2012: LEGACY SYSTEM HAS BEEN DISCONTINUED: IRBMED has ended all support for studies managed through the Legacy (paper) application system. The IRBMED office has administratively terminated all Legacy projects that were not migrated to the electronic system (eResearch) before December 23, 2011. If your study has been administratively terminated, you must suspend all research activities (such as enrollment, data collection, and data analysis) until you have re-submitted the study using eResearch and obtained IRBMED approval.

1/3/2012: NOMINATIONS FOR IRBMED VICE-CHAIR: Nominations for an IRBMED Vice-Chair are currently being solicited to fill the position vacated by Dr. Alan Sugar; Dr. Sugar was recently appointed a Co-Chair and is serving alongside Dr. Michael Geisser.

1/3/2012: MEET THE IRBMED: There will be a brief presentation followed by an open Question and Answer period. 

11/14/2011: NOMINATIONS FOR SERVICE ON IRBMED: IRBMED is currently in need of 'Community Members who are Non-Affiliated'. To be eligible for participation on the IRBMED as a community representative, neither the member nor any member of his/her immediate family may otherwise have a direct affiliation (i.e., as an employee, contractor, student in a degree program, or active emeritus faculty member) with the University. Immediate family includes spouse, parents, grandparents, children and grandchildren, brothers, sisters, mother-in-law, father-in-law, brothers-in-law, sisters-in-law, daughters-in-law, sons-in-law, adopted, half, and step members.

11/14/2011: FINAL NOTICE: END OF LEGACY SYSTEM: IRBMED is ending all support for studies managed through Legacy (paper) application system as of December 23, 2011.  All active Legacy projects must complete “Migration” to eResearch Regulatory Management (eRM).  Any studies that do not complete Migration will be Administratively Terminated December 23, 2011. Migration involves a new eRM application with special “pointers” to alert the IRBMED Board that the new application is not a new project, but a Migration of a former Legacy project.  If a study is administratively terminated, no research activities (e.g. enrollment, data collection or analysis) may take place until the study is re-submitted in eRM and approved as if a brand-new project.

11/14/2011: STARS UNAVAILABLE: IRBMED's Speak To A Regulatory Specialist (STARS) program will be unavailable on Tuesday, November 22, 2011, while staff attend an office retreat. During this time, you may submit your questions via email. IRBMED staff will return to the office on Wednesday, November 23.

11/14/2011: ORIO GUIDANCE AND REPORTING: IRBMED recently made a change to the webpage that contains the ORIO Guidance and Reporting. The timeline and guidance has not changed, but the page has been updated for ease of use. Please contact Monica Stiddom (647-1969 or mhealy@umich.edu) if you have any questions regarding this change.

11/1/2011: HOLIDAY CLOSURES: As the weather grows colder and the holiday season approaches the IRBMED Office would like to remind you that: 1. IRBMED Office will be closed and the review boards do not meet on Thursday, November 24, 2011, Thanksgiving Day, or on Friday, November 25, 2011. 2. The IRBMED Office will not be open for business during the holiday. The office will reopen on Tuesday, January 3, 2012, at 8:30 a.m.

10/20/2011: IRBMED’s PANEL DISCUSSION ABOUT RESEARCH PRIVACY AND HIPAA. Thank you to all who attended. We appreciated all of the great questions and hope that the session was beneficial. If you would like to review the presentation, you may access it by clicking here. A list of the Questions and Answers will be available soon. We would also like to especially thank the panelists for sharing their knowledge and expertise and all of the people that worked behind the scenes to make this event a success.

10/14/2011: IRBMED STAFF CHANGES: Aaron Rankin has been hired as the ARA of the B2 Board.

8/30/2011: REVISION TO THE INFORMED CONSENT TEMPLATE DOCUMENT AND INSTRUCTIONS: Changes were made to the format of the Informed Consent and Assent Template webpage and updated versions of the Consent and Assent Templates have been uploaded. The revised forms include easier to read Consent and Assent Completion Instructions as well as "clean" copies of the Consent and Assent Templates (without instructions). Additionally, as required by recent FDA mandate and US law, information regarding the posting of the study information on clinicaltrials.gov has been added to the Informed Consent form. The Informed Consent and Assent documents can be found at http://med.umich.edu/irbmed/ict.htm.

8/27/2011: IRBMED STAFF CHANGES: Cecilia Brenner, former ARA of the B2 Board, has accepted the JARA position of the B2 Board.

8/2/2011: IRBMED STAFF CHANGES: Pat Gordon, former JARA of the B2 Board, has accepted the eResearch Coordinator position.
Jennifer Galland has been hired as the Expedited Staff Reviewer.

8/2/2011: REVISION TO THE INFORMED CONSENT TEMPLATE DOCUMENT AND INSTRUCTIONS: Changes were made to the format of the Informed Consent and Assent Template webpage and updated versions of the Consent and Assent Templates have been uploaded. The revised forms include easier to read Consent and Assent Completion Instructions as well as "clean" copies of the Consent and Assent Templates with no instructions. Additionally, as required by recent FDA mandate and US law, information regarding the posting of the study information on clinicaltrials.gov has been added to the Informed Consent form. The Informed Consent and Assent documents can be found at http://med.umich.edu/irbmed/ict.htm.

8/1/2011: LEGACY: The Legacy (paper) Application System officially CLOSED on July 1, 2011. If you were unable to migrate your study prior to July 1, contact the IRB office immediately for instructions. The Legacy Migration documents can be found at http://www.med.umich.edu/irbmed/migration.html.

7/14/2011: Changes were made to the format of the Informed Consent and Assent Template page. In addition, an updated version of the Assent has been uploaded. This change created an easier to read Assent Form Instructions as well as a 'clean' copy of the Assent Template with no instructions. Similar changes to the Informed Consent documents are in progress.

7/14/2011: Changes to the Guidance regarding the Routine Reporting of Audits, Inspections, Reports and Correspondence to/from Oversight Bodies/Agencies/Entity. The URL for the page has also been changed. Please update any bookmarks.

6/17/2011: NEW DSMP GUIDANCE FOR AHRQ PROJECTS: Effective May 6, 2011, the Agency for Healthcare Research and Quality (AHRQ) issued notice
requiring the use of Data Safety and Monitoring Plans for studies meeting the following criteria: That is either AHRQ-conducted or -supported; Involves interventions with human subjects; and Presents greater than minimal risk to the subjects. For IRBMED’s guidance related to this change, please see: http://www.med.umich.edu/irbmed/guidance/AHRQ_DSMPs.html.

4/13/2011: TELEPHONIC CONSENT GUIDANCE CHANGED: On 4/13/11 changes were posted on the IRBMED website to the Telephonic Consent Guidance. The revised Guidance can be found at: http://med.umich.edu/irbmed/ict/TelephonicConsent-4-13-11.html.

3/25/2011: A change was made to the Informed Consent Template. We changed the Privacy and Compliance telephone number from 1-888-296-2481 to 1-866-990-0111. The revised forms are located on the IRBMED website at: http://med.umich.edu/irbmed/ict.htm.

2/1/2011: FDA Part 11 Electronic Signature Certifications and Assessments for eResearch and CareWeb -- These documents can be located at: http://med.umich.edu/irbmed/guidance/21cfr11.html.

2/1/2011: Changes were made to the Informed Consent Template. These changes include: Addition of language regarding Subject Injury and Instructions regarding International Research. The revised forms are located on the IRBMED web-site at: http://med.umich.edu/irbmed/ict.htm.

 

For Notices prior to 2011, please visit our Releases and Updates to IRBMED Website Archive.